Osimertinib for an older <i>de novo</i> T790M patient with chronic kidney disease

Satoh, Hiroaki; Hida, Norihito; Nakaizumi, Taisuke; Terashima, Hideo; Hizawa, Nobuyuki

doi:10.1111/ggi.13230

Cited by 5 publications

(5 citation statements)

References 2 publications

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“…Treatment with osimertinib 80 mg per day was well-tolerated without any adverse event. Another case report [113] also showed that 80 mg daily osimertinib was tolerated.…”

Section: Changes In the Pharmacokinetics And Clinical Response Of Tkimentioning

confidence: 97%

Decreased Disposition of Anticancer Drugs Predominantly Eliminated via the Liver in Patients with Renal Failure

Fujita

Matsumoto

Ishida

et al. 2019

CDM

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Background: Evidence has revealed that renal impairment can affect the systemic exposure of drugs which are predominantly eliminated via the liver. The modulation of drug-metabolizing enzymes and transporters expressed in the liver and/or small intestine by diverse entities, including uremic toxins, in systemic circulation of patients with severe renal failure is considered as the cause of atypical pharmacokinetics, which sometimes induce undesirable adverse events that are especially critical for drugs with narrow therapeutic window such as anticancer drugs. A dosing strategy for anticancer drugs in these patients needs to be established. Methods: The effects of renal impairment on the systemic exposure and safety of anticancer drugs were summarized. The proposed mechanisms for the alterations in the pharmacokinetics of these anticancer drugs were also discussed. Results: Changes in pharmacokinetics and clinical response were reported in 9 out of 10 cytotoxic anticancer drugs investigated, although available information was limited and sometimes controversial. Systemic exposure of 3 out of 16 tyrosine kinase inhibitors was higher in patients with severe renal failure than that in patients with normal kidney function. An increase in systemic exposure of anticancer drugs in patients with renal impairment is likely to be observed for substrates of OATP1B1, despite the limited evidence. Conclusion: The molecular basis for the effect of uremia on non-renal drug elimination still needed to be clarified with further studies to generate generalizable concepts, which may provide insights into establishing better clinical usage of anticancer drugs, i.e. identifying patients at risk and dose adjustment.

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“…Treatment with osimertinib 80 mg per day was well-tolerated without any adverse event. Another case report [113] also showed that 80 mg daily osimertinib was tolerated.…”

Section: Changes In the Pharmacokinetics And Clinical Response Of Tkimentioning

confidence: 97%

Decreased Disposition of Anticancer Drugs Predominantly Eliminated via the Liver in Patients with Renal Failure

Fujita

Matsumoto

Ishida

et al. 2019

CDM

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“…No clinical studies have been conducted to evaluate the effect of RI on the PK of osimertinib. Based on a population PK analysis, the osimertinib exposure was similar among patients with mild to severe RI and those with NRF (45, 46,89). Patients with ESRD have not been analyzed, but three case reports revealed that osimertinib at a dose of 80 mg orally once daily was safe and effective for patients with ESRD undergoing HD (90)(91)(92).…”

Section: Dose Adjustment Recommendations (Refs) --------------------mentioning

confidence: 99%

Dose adjustment for tyrosine kinase inhibitors in non‑small cell lung cancer patients with hepatic or renal function impairment (Review)

Zhao¹,

Chen²,

Long³

et al. 2020

Oncol Rep

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In recent years, a number of tyrosine kinase inhibitors (TKIs) have been approved for the treatment of non-small cell lung cancer. These novel treatments exhibit improved efficacy and toxicity when compared to conventional chemotherapy agents. TKIs are administered orally, which has the advantages of improved flexibility and convenience for the patients. However, challenges have arisen in the use of these novel agents. Prescribing drugs for patients with hepatic or renal function impairment poses a challenge for clinicians due to the large pharmacokinetic variability in each individual patient. Moreover, several TKIs have been shown to cause laboratory test abnormalities normally associated with hepatic or renal injury. The aim of the present review was to discuss the effects of hepatic and renal function impairment on the pharmacokinetic variability of 17 TKIs and their potential hepatotoxicity and nephrotoxicity, and to recommend dose adjustment for patients with hepatic or renal impairment.

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“…Although the first‐ and second‐generation TKIs for de novo EGFR T790M‐positive lung adenocarcinoma are ineffective, osimertinib is known to be effective [2–5]. However, there are no safety data on the first‐line osimertinib treatment in patients aged 75 years or older, defined as the elderly in Japan, and very few reports exist on the efficacy of first‐line therapy for de novo EGFR T790M‐positive lung cancer in elderly patients [2,3]. We report a safe and long‐term response to the first‐line treatment with osimertinib in de novo EGFR T790M‐positive patients older than 75 years.…”

Section: Introductionmentioning

confidence: 98%

“…Osimertinib is currently available for the first‐line treatment of EGFR mutation‐positive lung cancer and second‐line treatment for lung cancer harbouring an EGFR T790M mutation; however, a percentage of de novo EGFR T790M mutations exist before starting treatment [1]. Although the first‐ and second‐generation TKIs for de novo EGFR T790M‐positive lung adenocarcinoma are ineffective, osimertinib is known to be effective [2–5]. However, there are no safety data on the first‐line osimertinib treatment in patients aged 75 years or older, defined as the elderly in Japan, and very few reports exist on the efficacy of first‐line therapy for de novo EGFR T790M‐positive lung cancer in elderly patients [2,3].…”

Section: Introductionmentioning

confidence: 99%

Long‐term response to osimertinib in elderly patients with lung adenocarcinoma harbouring de novo EGFR T790M: a case report and literature review

Sumi

Kamada

Shijubou

et al. 2021

Respirology Case Reports

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Osimertinib is a potent and irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that selectively acts on both EGFR‐sensitive and EGFR T790M‐resistant mutations. Patients with pre‐treatment EGFR T790M mutations (de novo EGFR T790M) respond poorly to existing EGFR‐TKIs, whereas osimertinib has positive effects. However, the safety data for first‐line osimertinib treatment in patients aged >75 years are insufficient. We treated two elderly patients with de novo EGFR T790M mutations with osimertinib as the first‐line therapy. We found that the first‐line treatment with osimertinib was safe and resulted in a long‐term response in elderly patients with de novo EGFR T790M‐mutated lung adenocarcinoma.

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Osimertinib for an older de novo T790M patient with chronic kidney disease

Cited by 5 publications

References 2 publications

Decreased Disposition of Anticancer Drugs Predominantly Eliminated via the Liver in Patients with Renal Failure

Decreased Disposition of Anticancer Drugs Predominantly Eliminated via the Liver in Patients with Renal Failure

Dose adjustment for tyrosine kinase inhibitors in non‑small cell lung cancer patients with hepatic or renal function impairment (Review)

Long‐term response to osimertinib in elderly patients with lung adenocarcinoma harbouring de novo EGFR T790M: a case report and literature review

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